FDA Discusses Risk With Two Announcements

FDA Risk

FDA Discusses Risk Assessment

Today FDA released two documents to assist in assessing and communicating risk in FDA regulated products. The first is a strategic plan that some have noted contains recommendations that are three years old. The Associated Press reports:

The agency says it will begin studying public response to its announcements on potentially dangerous food and drugs. The plan posted online takes its cue from a 2006 report by the nonprofit Institute of Medicine, which found the FDA needed to do a better job communicating with the public.”

It should be noted that FDA has a very different leadership now than it did in 2006 and that Dr. Hamburg, the new FDA Commissioner, was only confirmed five months ago. Its nice to see that FDA now seems to be on the job. The announcement from FDA states:

“The plan defines three key areas–FDA’s science base, its operational capacity and its policy and processes – in which strategic actions can help improve the FDA’s communication about the risks and benefits of regulated products. The plan also identifies over 70 specific actions for the FDA to take over the next five years, including 14 that the agency commits to accomplishing over the next year.”

The second document is a draft guidance document on Risk Evaluation and Mitigation Strategies (REMS). This will become a very important factor in drug and biologic approvals and REMS will soon become a household acronym. The publishing of the draft guidance opens a 90-day public comment period. There should be a lively discussion among industry and consumer advocates. In its announcement FDA says:

The U.S. Food and Drug Administration today announced the availability of the first draft guidance for industry on Risk Evaluation and Mitigation Strategies or REMS, which are required for certain drugs or biologics.

The Food and Drug Administration Amendments Act of 2007 (FDAAA) granted the FDA the authority to require the submission and implementation of a REMS if the FDA determines a REMS is necessary to ensure that a drug’s benefits outweigh its risks.

REMS components include medication guides; patient package inserts; a communication plan for health care providers; elements to ensure safe use including requirements for those who prescribe, dispense, or use the drug; and a timetable for REMS submission.

UPDATE: Not everyone is thrilled by FDA’s focus on risk evaluation and mitigation. Forbes reports that FDA took too long to approve a Sabril, a drug for epilepsy and seizures, because the Agency determined that a REMS was necessary. Here’s what they say:

The FDA finally convened its panel in January 2009, and the panelists voted unanimously that Sabril should be approved both for babies with infantile spasms and for adults who had run out of options. In February, Lundbeck, a Danish drug maker, bought Ovation for $900 million. The press release announcing the deal trumpeted that Sabril was in the final stages of FDA review.

But Sabril needed a Risk Evaluation and Mitigation System (REMS), FDA jargon for a plan that ensures drugs are only used when benefits outweigh risks. One division was uncomfortable with the measurements on the dosing syringe in which the drug was given, and even after the review seemed close to done, a team of lawyers had to go over it. Sabril was finally approved in August.”

2 Responses to FDA Discusses Risk With Two Announcements

  1. sid olufs says:

    Change is coming, and it’s going to hurt. The hurt will be felt by those who pursue values other than protecting public health. I read through the FDA’s Strategic Plan For Risk Communication and was struck by how candidly it refers to bad management in the very recent past. The Report contains barely-veiled language that emphasizes the need to reorient FDA toward its core mission.
    As the Report says, one of the FDA’s central roles is “a public health agency, FDA is committed to protecting and promoting the public health.” Yes, and it is also in the business of approving drugs and devices that are seen by manufacturers as, in part, revenue streams. Companies want to be what they see as “treated fairly,” as ReGen argued in the case of Menaflex. There will be inevitable conflicts between public health and making money. Sorry, but FDA’s job is not a balancing act.
    How hard does FDA come down on drug companies that suggest physicians prescribe medicines for uses not approved by FDA? Well, that seems to depend on who is president. The Report refers to the sometimes lengthy negotiation between companies and FDA about what belongs on a product label. Perhaps this is one of the reasons for the Report’s recommendation to “(c)larify roles and responsibilities of staff involved in drafting, reviewing, testing, and clearing messages.” Yes, please do.
    One feature of the Report that is somewhat troubling is the underlying model of the relationship between the FDA, private sellers of goods and services, and consumers. Many points in the report hinge on the need of the FDA to communicate both benefits and risks to consumers, who can then do the balancing of values themselves. That might work for people who are sufficiently trained and have the discretion (through leisure time, money to purchase alternatives, etc.) to act on the information.
    This takes us back to the sentence, quoted above, about the FDA being a public health agency. The next sentence: “The effectiveness of all of FDA’s risk communication activities must ultimately be measured against how successfully we achieve this goal.”
    Yes, precisely. We need to measure the actual outcomes of FDA risk communication policies. If warning consumers about unhealthy food choices does not change behavior, has FDA fulfilled their role? If physicians continue to prescribe non-approved uses for a drug, is that just the breaks? A public health bottom line steers FDA in a particular direction on such questions, a new direction.
    The Report should be read in conjunction with the earlier report, The Future of Drug Safety (Institute of Health, 2007) which pointedly recommends that the head of the FDA be a person who can actually run a scientific organization, be insulated from political pressure as much as possible, and that FDA procedures be changed to emphasize safety and effectiveness—several times in that report the authors refer to failures to protect public health and procedures “insufficiently attentive to safety.”
    Watching the news about FDA and its new Commissioner these last few months tell us it is a new day.

    • Carl's Blog on FDA Stuff says:

      Do you have a link or source to the report you mention: The Future of Drug Safety (Institute of Health, 2007)? In addition, the request for postmarket surveillance studies for implantable devices that was posted recently is another indication of the increased emphasis on risk evaluation.

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